New discussion Hiring for Sr. Application Engineer - Deviation (Very Urgent) at San Mateo, CA and looking for suitable candidates.

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Group: IT Recruiters Goutam Kar has started a discussion: Hiring for Sr. Application Engineer - Deviation (Very Urgent) at San Mateo, CA and looking for suitable candidates. "Single Click Job Sharing on Multiple Linkedin Groups with Wisestep.com. Apply Online: http://www.wisestep.com/RNFPUSQO/IRDGFLIGEK or Share with Friends. Job Description: Description The Sr. Application Engineer serves as the system manager and the primary point of contact for Enterprise Quality Management system supporting CAPA, Deviation, Audit and Change management systems. This role partners with IT and business to create the strategy, services, configuration and processes in the Quality Management space. Technical Responsibilities: 1.Strong understanding of CAPA, Deviation processes in a regulated/pharmaceutical environment 2.Strong understanding of Change management and Audit processes? in a regulated/pharmaceutical environment 3.Extensive Hands-on experience? with configuration, implementation, validation and support of Sparta Systems Track Wise is required. 4.Additional experience with other Quality systems? such as Smart Solve will be a plus. 5.Experience with regulations like CFR 21? Part 11 and Annex 11. 6.Experience with Computer System Validation and GxP? Compliance 7.Good written, verbal, and interpersonal communication skills 8.Manages the business needs of a specific area of the business with IT. 9.Implements IT strategy determined by the senior management group in a specialized business functional area. 10.Assesses and analyzes business requirements and recommends solution and plan. 11.Defines implementation? methodology and recommends resources required to deliver the business application outlined by the senior management group. 12.Partner with? specific business unit(s) or department(s) to lead the implementation, provide ongoing support and manage a business application. 13.Coordinates the work? activities of assigned IT staff or other project team members on project-oriented tasks. 14.Develops opera?ting procedures in accordance to the IT strategic plan. Works on validation efforts in accordance with GxP requirements. Provide performance tuning strategies 15.Joint reviews with clients technical team 16.Need to work with TCS onshore offshore model Relevant Years of Experience: 8 years (in IT) 1.Bachelors degree in Computer Science, Engineering or related field 2. 8+ Years IT experience with BS/BA, 6+ Years with MS/MA or MBA 3. 3+ years? experience supporting systems in Life Sciences Industry Must Have Technical Qualifications: 1.Extensive Hands-on experience with configuration, implementation, validation and support of Sparta Systems TrackWise is required. 2.Strong understanding of CAPA, Deviation processes in a regulated/pharmaceutical environment 3.Strong understanding of Change management and Audit processes in a regulated/pharmaceutical environment 4.Additional experience with other Quality systems such as SmartSolve will be a plus. 5.Experience with Computer System Validation and Compliance 6.Good written, verbal, and interpersonal communication skills Must Have Business Qualifications: <br"

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